Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

The goal of this clinical trial is to compare ARINA-1 plus Standard of Care vs Standard of Care alone. The main question it aims to answer are: - Evaluate the effectiveness of ARINA-1 in preventing bronchiolitis obliterans syndrome (BOS) progression in participants with a bilateral lung transplant - To evaluate the effectiveness of ARINA-1 on improving quality of life decline and preventing or delaying the use of augmented immunosuppression in participants with pre-BOS relative to SOC. Participants will have clinic visits at screening, randomization (day 1) and weeks 4, 12, 18, and 24. After week 24, participants will have clinic visits at weeks 32, 40, and 48. Participants will also have a telehealth visit on day 2 and phone calls to assess adverse events (AEs), serious adverse events (SAEs), and review patient education will occur during weeks 5, 8, 36, and 44.

Official Title

A Phase 3, Open-label, Randomized, Standard of Care-controlled, Parallel Study Arm Study to Demonstrate Efficacy and Safety of ARINA-1 in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) Progression in Participants With a Bilateral Lung Transplant

Keywords

Pre-Bronchiolitis Obliterans Syndrome, Bronchiolitis, Bronchiolitis Obliterans, Syndrome, ARINA-1

Eligibility

You can join if…

Open to people ages 18-75

  1. Bilateral lung transplant >12 months from the time of Visit 1 / Randomization
  2. Age 18-75 years old at the time of consent
  3. Routinely followed at enrolling site
  4. Willing and able to comply with visit schedule and at-home requirements
  5. 10-20% decrease in FEV1 from the post-transplant baseline within the last 12 months.
  6. Capable of giving informed consent
  7. On a stable maintenance regimen of azithromycin for >4 weeks prior to Screening
  8. On a stable 3-agent immunosuppression regimen that includes a steroid, a calcineurin inhibitor (CNI), and cell cycle inhibitor (e.g., mycophenolate) >4 weeks prior to Screening

You CAN'T join if...

  1. Positive urine pregnancy test at screening and baseline visit
  2. Diagnosis of active congestive heart failure or symptomatic coronary artery disease > grade 3 based on the New York Heart Association Functional Classification (NYHA) criteria
  3. Restrictive allograft syndrome (RAS) defined by radiographic interstitial or alveolar opacities on chest X-ray or CT scan that are consistent with RAS
  4. Advanced BOS (BOS 1-4) defined by >20% decrease in FEV1 in post-transplant baseline
  5. A diagnosis of probable antibody-mediated rejection (AMR) <12 months prior to the baseline visit
  6. Donor-specific antibodies (DSA) identified <6 months prior to the baseline visit. *The presence of DSA >6 months from the baseline visit is acceptable for enrollment into the study.
  7. Unresolved diffuse alveolar damage
  8. Receiving mechanical ventilation
  9. Chronic kidney disease stage IV or higher, including on dialysis
  10. . Initiating a new maintenance therapy or changing immunosuppression maintenance therapy (e.g., changing tacrolimus to cyclosporine) <30 days prior to the baseline visit.
  11. . Currently using an mTOR inhibitor or azathioprine
  12. . Initiating or changing antibiotic (including azithromycin), antiviral, or antifungal therapy <14 days prior to the baseline visit.
  13. . Use of alemtuzumab <6 months prior to the baseline visit
  14. . Use of anti-thymocyte therapies (e.g., anti-thymocyte globulin) or photopheresis <90 days prior to the baseline visit
  15. . Initiating a multivitamin or other supplement (inhaled, oral, or IV) containing vitamin C, glutathione, or N-acetylcysteine <90 days prior to the baseline visit
  16. . Significant unstable comorbidities, in the opinion of the site investigator
  17. . Allery or previous adverse reaction to azithromycin
  18. . A diagnosis of dynamic collapse / tracheobrochomalacia or endobronchial stent <90 days of the baseline visit.
  19. . Subjects currently participating in, or who have participated in an interventional (drug or device) clinical study <30 days of the baseline visit.

Locations

  • University of California at San Diego not yet accepting patients
    San Diego California 92103 United States
  • University of California Los Angeles (UCLA) not yet accepting patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Renovion, Inc.
ID
NCT05654922
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated